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Policy for Permitted Medical Applications

of Excel Polymers LLC Materials

(the “Policy”)

(As of April 22, 2008)

 

Excel Polymers LLC (“Excel”, “we” or “our”) categorizes the use of our materials in medical applications into three distinct categories.  Each category provides a guideline that reflects our corporate policy for the sale and use of our materials for a particular medical application.  This Policy should not, however, be construed as any representation, promise, express warranty or implied warranty concerning the suitability of any of our materials for any particular medical application or purpose.  Customers using any of our materials are solely responsible to confirm fitness for a particular use, including, but not limited to, any product testing, clinical medical studies or implementation of any medical application.  We categorize medical applications into the following three categories:

 

Category 1:    Medical applications that involve the permanent implantation into the body or direct contact with bodily fluids or tissues for a period of 24 hours or more.

 

Excel Policy:     We do not supply or support the use of any of our materials in connection with medical applications within this Category 1.  Any sales requests for our materials for a Category 1 use shall be expressly denied in writing.

 

 

Category 2:    Medical applications that involve contact with bodily fluids or tissues for a period of less than 24 hours.

 

Excel Policy:     We require a senior corporate level management review involving at least one representative from senior management and one representative from technology prior to the sale or supply of our materials in connection with any Category 2 medical applications (the “Review”).  The Review shall undertake, at a minimum, an analysis of (1) the appropriate pricing based on the risk premium for such medical application, (2) the application, use and disposal of our materials being used in connection with the medical application, (3) the desirability of requiring separate general liability insurance coverage for such medical application and (4) the customer’s viability and ability to indemnify Excel against certain liabilities related to such medical application.  Sales for Category 2 medical applications require a written contract that clearly addresses each of the factors analyzed in the Review and provides that the use of our materials for such medical application is projected to result in minimum sales by Excel of [$5,000,000].

 

Category 3:    Medical applications that involve no contact with bodily fluids or tissues.

 

Excel Policy:     We do not require any specific approval for such applications.  However, we shall inform such customer, in writing, of this Policy and must obtain written confirmation from such customer that any use of our materials in connection with such medical application will be solely limited to the uses specified within this Category 3.

              Doc 1478794   Ver 2

 

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